Tanvex CDMO is Now Bora Biologics ยท 1 day ago
QC Associate II, Microbiology
San Diego, CA
Full-time
Onsite
New Grad, Entry Level
$49K/yr - $58K/yr
0+ years expTanvex CDMO, now known as Bora Biologics, is seeking a Quality Associate in Microbiology. The role involves conducting microbiological testing and environmental monitoring to ensure compliance with cGMP standards and supporting product release activities.
Pharmaceuticals
Responsibilities
Conduct Bioburden and endotoxin testing of in-process and products samples
Perform environmental monitoring (EM) of classified cleanrooms and controlled areas
Collect and test water samples from purified water and WFI systems
Maintain accurate and compliant documentation in accordance with cGMP, GDP, and internal SOPs
Assist in investigations of microbiological deviations and support CAPA implementation
Collaborate cross-functionally with Manufacturing, QA, and Validation teams
Perform sample management functions, such as receiving, logging, tracking, storing, and disposal of samples in accordance with SOPs and regulatory requirements
Other duties as assigned
Qualification
Required
BS or advanced degree in a related scientific discipline, or equivalent combination of education and experience
BS with 0-2 years of progressively responsible experience in pharmaceutical or biologics production environments, or equivalent combination of education and experience
Working knowledge of GLP and cGMP regulations 21 CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices
Knowledge of standard laboratory equipment
Basic understanding of microbiological techniques, aseptic practices, and laboratory safety
Good organizational and problem-solving skills
Ability to follow written procedures and work in a regulated environment
Must always adhere to good documentation practices
Detail oriented with strong written and verbal communication skills
Ability to work independently, within prescribed guidelines, or as a team member
Willingness to work in cleanroom settings and handle biohazardous materials under proper PPE and gowning protocols
Experience with Microsoft suite (e.g. PowerPoint, Word, and Excel)
Company
Tanvex CDMO is Now Bora Biologics
Tanvex CDMO is now Bora Biologics. Please follow us at: https://www.linkedin.com/company/bora-biologics/
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Peter L.
Chief Financial Officer
Company data provided by crunchbase